AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 used to power the following devices: Nada CI Q90 Sound Processor (CI-5280), Nada CI Q70 Sound Processor (CI-5245) and Nada CI Q30 Sound Processor (CI-5260). For cochlear implant.
- Company
- Advanced Bionics, Llc
- Recall Initiated
- September 26, 2020
- Posted
- November 25, 2020
- Terminated
- May 4, 2023
- Recall Number
- Z-0487-2021
- Quantity
- 28 units
- Firm Location
- Valencia, CA
Reason for Recall
Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.
Distribution
Worldwide distribution - US Nationwide distribution including in the states of NY, IL, MA, NE, CA, HI, LA, MS, AL, FL, SC, OH and the countries of Belgium, Germany, Italy Netherlands, Spain, Colombia, Czech Republic, Iran, Kuwait, Panama, Peru, Taiwan, Italy.
Lot / Code Info
410078519
Root Cause
Under Investigation by firm
Action Taken
On 9/26/2020 Advanced Bionics sent a "Field Correction Notification" to affected customers informing them about the mislabeled PowerCel Batteries. On October 5, 2020, Advanced Bionics sent a follow-up email to affected consignees. In addition, to informing consignees about the recall, the firm provided each affected consignee with the correct battery.